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pseudoephedrine (Efidac/24 / Sudafed 24)

✓ Approved

Johnson & Johnson Services, Inc. · Small Molecule · Small Molecule

What is pseudoephedrine?

pseudoephedrine is a small molecule developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesEfidac/24, Sudafed 24
CompanyJohnson & Johnson Services, Inc.
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Johnson & Johnson Services, Inc.

Therapeutic Indications

pseudoephedrine is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Immune system disordersHypersensitivity✓ Approved
Infections and infestationsRespiratory tract infection✓ Approved

Related Research Articles

PubMedFrontiers in pharmacology2026-08-26

The impact of patient age on the pharmacist's recommendation of OTC anti-common cold products before and during the COVID-19 pandemic.

Kopa-Stojak Paulina Natalia PN, Pietrusiewicz Malgorzata M, Pawliczak Rafal R

A pharmacist is the first point of contact when a patient seeks the most effective over-the-counter treatment, usually for a self-diagnosed disease, especially in the case of difficult or limited access to medical practitioners. The aim of this study is to determine the impact of the patient's age on the pharmacist's recommendation of over-the-counter anti-common cold treatment before and during the COVID-19 pandemic. This study is based on a self-developed questionnaire about pharmacists' recommendations for patients with cold symptoms collected in four large network community pharmacies in Lodz, Poland, before and during the COVID-19 pandemic. Pearson's chi-square test and odds ratios with 95% confidence intervals were used to determine the relationship between the patient's age and frequency of medication recommendations. The Mann-Whitney U test was used to determine differences in recommendations between the analyzed periods. We report higher odds of pharmacists' recommendations (odds ratio > 1; p < 0.01667) for ibuprofen with pseudoephedrine for patients aged 18-40 years, paracetamol with ascorbic acid, and phenylephrine HCl, acetylcysteine, other soluble products, and other tablets/capsules for patients aged 61-90 years before the COVID-19 pandemic. Moreover, there were higher odds of recommendations for paracetamol with ascorbic acid and phenylephrine HCl, inosines, and other soluble products for the 41-60 age cohort, and for homeopathic and herbal products for the 61-90 age cohort during the pandemic. Patients, especially older people who take several medications, require special attention when being advised about over-the-counter (OTC) medications. Our findings clearly demonstrated the constant need for improving pharmacists' counseling regarding OTC medicines (i.e., age-, comorbidities-, and drug-drug-interaction-adapting recommendations) by training and increasing professional skills.

PMID 42643370
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PubMedForensic science international2026-08-24

LC-MS/MS-based impurity profiling of high-purity methamphetamine for precursor identification and regional comparison.

Kim Se-Eun SE, Bae Hyunah H, Kim Heeseung H

Methamphetamine (MA) is a widely abused illicit drug synthesized primarily using either ephedrine/pseudoephedrine or 1-phenyl-2-propanone (P2P) as precursors. These processes generate precursor-derived impurities that can provide valuable forensic intelligence. However, recent advances in purification techniques have resulted in refined MA samples containing impurities at ultra-trace levels, thereby posing analytical challenges for conventional gas chromatography-based methods. In this study, a highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the targeted detection of MA precursor-associated impurities at ultra-trace levels. A total of 19 impurities, including markers associated with the P2P and ephedrine/pseudoephedrine precursor classes, were analyzed using multiple reaction monitoring (MRM) mode. Chromatographic and mass spectrometric conditions were optimized to achieve high sensitivity and selectivity. The developed method demonstrated limits of detection ranging from 0.008 to 2.500 ng/mg and showed satisfactory selectivity and repeatability for qualitative identification. The method was applied to 33 high-purity seized MA samples to evaluate precursor-associated impurity profiles and regional differences based on documented geographical origins. Differences in impurity patterns were observed between samples from North America and Southeast Asia, reflecting regional variation in these profiles. P2P-related impurities were detected in North American samples, whereas Southeast Asian samples exhibited more variable profiles, including both P2P- and ephedrine/pseudoephedrine-related markers. These results demonstrate that the proposed LC-MS/MS method enables reliable detection of ultra-trace level impurities and provides a valuable analytical tool for impurity profiling and forensic intelligence applications, particularly for highly purified MA samples.

PMID 42636747
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PubMedSubstance use & misuse2026-08-17

Underrecognized Substance Exposure in Pediatric Emergency Departments: Insights from Universal LC-MS/MS Confirmation.

Kardaş Zehra Z, Kondolot Meda M, Karakükçü Çiğdem Ç, Koçer Derya D et al.

Substance exposure among pediatric emergency department (ED) patients may be underrecognized because routine urine immunoassays have limited analytical sensitivity, and objective confirmatory toxicological data in pediatric ED populations remain limited. This dual-phase observational study included patients aged 6-18 years who underwent toxicological assessment in two tertiary pediatric EDs in Central Anatolia, Türkiye. The retrospective phase (2018-2021) tested each sample by either immunoassay or LC-MS/MS, depending on time of collection, but not both. The prospective phase (January 2022-2023) enrolled clinically suspected cases, all tested by both methods regardless of screening result. Logistic regression evaluated factors associated with liquid chromatography-tandem mass spectrometry (LC-MS/MS)-confirmed positivity in the prospective cohort. Results: A total of 1039 patients were included (852 retrospective; 187 prospective). In the retrospective cohort, immunoassay screening (n = 570) identified positivity in 19.8% (113/570), while LC-MS/MS on a separate subset (n = 282) identified 32.6% (92/282); these derive from non-overlapping subsets, not paired testing. In the prospective cohort, LC-MS/MS positivity was 11.2% (21/187) by standard cutoff and 18.8% (35/187) with an exploratory limit of quantitation (LOQ)-supported benzodiazepine interpretation (after excluding 18 pseudoephedrine/ephedrine-only patients). Benzodiazepines and amphetamine-type stimulants were most frequently detected. Younger age, psychiatric illness, and daily screen exposure >3 h were independently associated with positivity. Immunoassay screening showed high specificity but limited sensitivity against LC-MS/MS. Conclusions: Routine immunoassay screening may substantially underestimate pediatric substance exposure in ED settings. LC-MS/MS provides broader and more sensitive toxicological detection, though differences also partly reflect broader analyte coverage rather than sensitivity alone.

PMID 42605130
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PubMedBMJ military health2026-08-11

.Degradation of active drugs in medicinal vials exposed to temperature extremes encountered during military operations: the Military Medication Temperature Effect Study.

Shah Shreyans S, Wu Charlene C, Sime Fekade F, Wallis Steven S et al.

Maintaining the activity of pharmaceuticals and preventing the accumulation of harmful degradation products during storage are essential for efficacy and safety, particularly for non-titrated medications such as antibiotics. Although manufacturers' storage instructions usually specify a target controlled temperature, military operations often occur in extreme environments with substantial temperature variability. No manufacturer provides data to guide decisions under such circumstances. This study assessed the stability of 10 medications commonly used in the Australian Defence Force (ADF) prehospital setting when subjected to operationally relevant temperatures. 10 medications (pseudoephedrine, cefazolin, tranexamic acid, ceftriaxone, hydrocortisone, benzylpenicillin, promethazine, ketorolac, amiodarone and metoclopramide) were stored for 14 or 28 days under five conditions: -20°C, 30°C, 50°C, 30°C-50°C diurnal cycling and ambient control (24°C±1°C). Stability was assessed by recording pH, visual appearance, subvisible particle count distribution and intact content using validated physicochemical and chromatographic methods. Changes exceeding the coefficient of variation (CV) of ambient control replicates were flagged as signs of potential instability. Nine of the 10 medications retained ≥90% of original content across all conditions and met criteria for stability according to visual appearance, pH and subvisible particle formation. However, after 14 days at 50°C, cefazolin content fell below this threshold (87.7%), and the CV in pH failed the acceptance criterion. Minor fluctuations above control CV were also noted for tranexamic acid, promethazine and pseudoephedrine, but no significant degradation trends emerged. Most of the medications tested retained acceptable physicochemical characteristics over 28 days under conditions simulating field exposure. These findings provide preliminary support that some medications may remain suitable for use when manufacturer-recommended temperatures cannot be maintained, and resupply is unlikely. However, the single sample (n=1) study design limits confidence in the findings. Further replicated studies are required before these results should inform medicines management policy.

PMID 42580819
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PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-08-06

Pseudoephedrine poisoning reported to German poison centers: analysis of documented patient cases and the particular vulnerability of infants and toddlers.

Gezgin Funda F, Eyer Florian F, Zorn Gabriel G, Schaper Andreas A et al.

Poison centers (PCs) in Germany are medical facilities that serve as points of contact for cases of poisoning or suspected poisoning and are available by phone 24 h a day. Consultations are provided by physicians who have completed specialized training in toxicology. Members of the public, healthcare professionals, and institutions with questions regarding toxicology can seek advice from the PCs. Over-the-counter medicines play an important role when contacting the PCs. These include pseudoephedrine (PSE), an indirect sympathomimetic, which is used in Germany as a combination preparation for the treatment of cold and flu symptoms and for the symptomatic treatment of allergic rhinitis. In Germany, PSE is combined with acetylsalicylic acid, acetaminophen, or ibuprofen, as well as with first- and second-generation H1 receptor antagonists. PSE has a decongestant effect on the mucous membranes of the nose and sinuses but also has stimulating effects and causes a feeling of alertness. This study includes an analysis of PSE poisoning cases reported to German PCs. They were asked to provide information on documented cases of PSE poisoning. Three of the seven centers surveyed provided their data (Erfurt 136 cases, Göttingen 175 cases, and Munich 210 cases, overall n = 521). The individual cases were then analyzed in terms of various aspects. The patient cases analyzed revealed age-related differences, with a higher incidence in childhood, particularly among children under 6 years of age. There were also indications of gender-specific differences. At the PC Erfurt, cardiovascular and neurological events predominate, with a male dominance. In Munich, neurological and gastrointestinal symptoms predominated. However, a high proportion of cases with unknown gender made gender-specific classification difficult. In Germany, young children up to the age of six are more severely affected despite contraindications and account for a significant proportion of inquiries to PCs. In recent years, PCs in Germany have reported an increase in cases of poisoning involving PSE combination preparations. A variety of symptoms have been observed in connection with PSE poisoning. As a preventive measure, it would be advisable for physicians-particularly pediatricians-and pharmacists to provide better patient education to raise awareness of the risks. Public platforms could also be used to conduct more educational outreach. Overall, the clinical relevance of PSE poisoning is evident from the present findings, which therefore require increased attention. PCs play an important role in this regard by providing acute consultation and systematically collecting data. However, the present findings should be interpreted in light of the limited data available to PCs.

PMID 42560552
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PubMedCureus2026-08-02

Mycoplasma pneumoniae-Associated Reactive Infectious Mucocutaneous Eruption Mimicking Atypical Stevens-Johnson Syndrome: A Case Report.

Burbea Alexandru C AC, Verlekar Pankaj P

Reactive infectious mucocutaneous eruption (RIME) is an infection-associated mucositis syndrome previously described under terms including incomplete Stevens-Johnson syndrome (SJS), Fuchs syndrome, and Mycoplasma pneumoniae-induced rash and mucositis (MIRM). It is characterised by an infectious prodrome, prominent mucosal involvement, and sparse or absent cutaneous disease. Severe ocular involvement may clinically mimic atypical Stevens-Johnson syndrome. We report the case of a previously healthy woman in her 20s who developed coryzal symptoms and self-treated with ibuprofen, paracetamol, and pseudoephedrine before presenting with worsening cough, pyrexia, odynophagia, and bilateral conjunctival discharge. She received doxycycline and topical chloramphenicol but re-presented overnight with rapidly progressive lip swelling, dysphagia, oral mucosal ulceration, and severe bilateral ocular inflammation without cutaneous lesions. Recent exposure to non-steroidal anti-inflammatory medication and doxycycline created initial diagnostic uncertainty, while the preceding respiratory prodrome and skin-sparing mucositis supported infection-associated RIME. Ophthalmological assessment demonstrated severe ocular surface inflammation with pseudomembrane formation, early symblepharon, and progressive corneal involvement, requiring tertiary transfer and amniotic membrane grafting. Initial chest radiography and respiratory multiplex polymerase chain reaction (PCR) testing were negative, including for Mycoplasma pneumoniae; however, subsequent serology returned positive for Mycoplasma pneumoniae IgM. Later drug challenge testing demonstrated tolerance to suspected medications, supporting an infection-associated rather than drug-induced aetiology. This case highlights that Mycoplasma pneumoniae-associated RIME may mimic atypical Stevens-Johnson syndrome, particularly when severe ocular and oral mucositis occurs after recent medication exposure. Early dermatology and ophthalmology involvement, combined molecular and serological testing, and prompt ocular treatment are essential to reduce long-term ocular morbidity.

PMID 42540076
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